BEUDAMED
    FDA Recall Terminated

    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.

    Recall: Z-2241-2010 · Initiated March 23, 2010

    Recall

    Recall Number
    Z-2241-2010
    Event Number
    55153
    Firm
    Dental Equipment LLC
    FEI Number
    1000523896
    Product Code
    NRU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2010
    Posted
    August 20, 2010
    Terminated
    January 4, 2012
    Address
    705 S Springbrook Rd, Bldg B200, Newberg, OR, 97132-7057

    Description

    The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED ITEM, NOT THE CHAIRS): The dental chairs are sold under the brand names Marus and DCI Equipment. The affected models are: Marus MaxStar-Agency Model # DC1490; Marus MaxStar-Agency Model # DC1690; Marus NuStar-Agency Model # DC1700; Marus NuStar-Agency Model # DC1702; Marus ProStar-Agency Model # DC1540; Marus ProStar-Agency Model # DC1535; DCI Equipment DC1235 Hydraulic-Agency Model # DC1235; and DCI Equipment DC1335 Electromechanical-Agency Model # DC1335.

    Reason

    The magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond to a magnet.

    Action

    DCI Equipment sent an "Urgent Field Safety Alert" letter dated March 15, 2010 to consignees advising them of the potential problem. The letter instructed that patients with implantable pacemakers or defibrillators should avoid dental chairs with the magnetic headrest. A warning label was sent with the letter for insertion into the product Use and Care manual for operator warning. Consignees were asked to complete a Field Safety Alert Acknowledgement/Return Form and fax to the firm. Consignees were requested to notify customers.Consignees may contact the firm at 503 537-3602.

    Distribution

    Worldwide distribution in the USA and Canada.

    Quantity

    108